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NCT Number: NCT04972682

[SENTRY] Tailoring Postoperative Management Through Sentinel Lymph Node Biopsy in Low- and Intermediate-Risk Endometrial Cancer

While total hysterectomy without lymph node staging is standard for low- and intermediate-risk endometrial cancer, certain histopathologic factors can necessitate additional interventions. Our study assesses the influence of sentinel lymph node (SLN) biopsy on postoperative decision-making.

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Key information

Conditions

Endometrial Cancer Endometrial Adenocarcinoma Endometrial Cancer Stage I Endometrial Cancer Stage II Endometrial Endometrioid Adenocarcinoma Endometrial Neoplasms Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Genital Neoplasms, Female Hysterectomy Laparoscopic Hysterectomy Neoplasms Neoplasms by Site Sentinel Lymph Node Urogenital Diseases Urogenital Neoplasms Uterine Diseases Uterine Neoplasms

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

1. Department of Gynecologic Oncology, Moscow City Oncology Hospital No. 62

Istra, Moscow Oblast, 143515, Russia

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age ≥18 years
  • Histologically verified low-grade endometrioid adenocarcinoma of the endometrium (G1-G2)
  • FIGO stage IA
  • FIGO stage IB and II when LND is contraindicated
  • No contraindications for surgery
  • Signed informed consent

Exclusion criteria

  • • Age <18 years
  • Presence of tumor spread outside the corpus uteri
  • Absence of tumor invasion into the myometrium
  • High-grade tumor (G3)
  • Bokhman type 2 tumor (e.g., clear cell adenocarcinoma, serous adenocarcinoma, carcinosarcoma, endometrial stromal sarcoma)
  • Preoperative treatment of endometrial cancer including radiotherapy, systemic chemotherapy, or hormone therapy
  • Prior pelvic or retroperitoneal LND
  • History of surgeries on the uterus and uterine appendages, with exceptions such as cesarean section, tubectomy, oophorectomy, ovarian resection, ovarian biopsy, and ovarian cauterization
  • Allergy to iodine-containing drugs
  • Contraindications to surgical treatment
  • Lack of signed informed consent

Treatment and study plan

Laparoscopic total hysterectomy with bilateral salpingo-oophorectomy and sentinel lymph node biopsy

Procedure

Laparoscopic total hysterectomy, bilateral salpingo-oophorectomy (BSO), and sentinel lymph node (SLN) biopsy are executed by 1 of 5 experienced gynecologic oncologists. SLN mapping utilizes indocyanine green (ICG) at a standard concentration of 2.5 mg/mL - 1 mL is injected into the cervix at the 3 and 9 o'clock positions (total dose - 5 mg) to a depth of 5-10 mm, initiated right after general anesthesia induction. Diagnostic laparoscopy employs the Image 1S equipment (KARL STORZ©, Tuttlingen, Germany). Upon examination, fluorescence in the near-infrared spectrum is observed. Successful mapping is indicated by identifying a lymphatic vessel with at least one LN. Detected SLNs are then extracted, and the total hysterectomy with BSO is completed. SLN frozen section remains at the surgeon's discretion. If metastasis surfaces in the SLN either during the frozen section or routine assessment, the option for systematic LN dissection in a subsequent procedure exists although not mandatory.

Primary outcomes

  1. Change in postoperative treatment strategy

    Time frame: Up to 3 weeks after surgery

    The rate of change in postoperative treatment based on the SLNB results and postoperative histology (percentage). A change in postoperative treatment strategy is defined as any difference between treatment plans set by the tumor board before and after receiving the SLN biopsy information.

Secondary outcomes

  1. Adjustments in FIGO staging

    Time frame: Up to 3 weeks after surgery

    The rate of change in disease stage based on SLNB results and postoperative histology (percentage).

  2. Bilateral SLN detection

    Time frame: At the end of the surgery - 1 day

    The rate of bilateral SLN detection (percentage).

  3. Details of intraoperative complications of SLN biopsy

    Time frame: At the end of the surgery - 1 day

    The actual list of intraoperative complications associated with SLN mapping and biopsy. They include but are not limited to an intraoperative bleeding, small and large bowel injury, ureter and bladder injury, nerve injury, and allergic reaction to indocyanine green (ICG).

  4. The rate of intraoperative complications of SLN biopsy

    Time frame: At the end of the surgery - 1 day

    Percentage of patients experiencing intraoperative complications associated with SLN mapping and biopsy listed above.

  5. Major postoperative morbidity

    Time frame: Up to 30 days after surgery

    Major postoperative morbidity following the procedure (percentage).

  6. Postoperative mortality

    Time frame: Up to 30 days after surgery

    Postoperative mortality following the procedure (percentage).

  7. Incidence of lymphedema

    Time frame: Up to 24 months after surgery

    The rate of lower extremities lymphedema (percentage).

  8. Pelvic recurrence rate

    Time frame: 24 months after surgery

    The percentage of patients experiencing pelvic recurrence after surgical treatment.

  9. Time to pelvic recurrence

    Time frame: 24 months after surgery

    Time from surgical treatment to detected pelvic recurrence in months.

Sponsors and collaborators

Lead sponsor

Moscow City Oncology Hospital No. 62

Other Gov

Registry information

Official study title

Tailoring Postoperative Management Through Sentinel Lymph Node Biopsy in Low- and Intermediate-Risk Endometrial Cancer: a Prospective Open-label Single-arm Clinical Trial

Acronym: SENTRY

Important dates

Study start
2021
Primary completion
2023
Study completion
2024
First posted
Jul 22, 2021
Registry last updated
May 7, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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